Browse Device Recalls
34,608 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,608 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 34,608 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 16, 2026 | MEDLINE ANTERIOR HIP PACK DYNJ64672B | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2... | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK,... | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DY... | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898... | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Airway Exam Kit, DYKE1796 | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | THORACIC ROBOTS, DYNJ908777B | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... | Class II | Medline Industries, LP |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| Feb 16, 2026 | Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm | Drainable large pouch may leak due to manufacturing issue. | Class II | ConvaTec, Inc |
| Feb 13, 2026 | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 530G Insulin Pump (MMT-551, MMT-751) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC | Connectors were not manufactured to required dimensional specifications and may not form a proper... | Class II | Medline Industries, LP |
| Feb 13, 2026 | Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE C... | Connectors were not manufactured to required dimensional specifications and may not form a proper... | Class II | Medline Industries, LP |
| Feb 13, 2026 | Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm Insulin Pump (MMT-712, MMT-715) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 620G Insulin Pump (MMT-1750) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 12, 2026 | Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 12, 2026 | Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite au... | Class II | Olympus Corporation of the Americas |
| Feb 11, 2026 | Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Kilt | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Caps. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Thyroid Shield. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Blockers. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Frontal Aprons | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Protective Sleeves. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Kilt Blockers. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Demi Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Vest | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Leg Wraps. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Burlington Medical, Wrap Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Burlington Medical, LLC |
| Feb 11, 2026 | Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 11, 2026 | Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article nu... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 11, 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be ... | Class II | CareFusion 303, Inc. |
| Feb 10, 2026 | Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAG... | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory respo... | Class II | Medline Industries, LP |
| Feb 10, 2026 | Artegraft Vascular Graft; REF#: AG740; | Labeling mix-up resulting in the incorrect lot outer packaging of product. | Class II | LeMaitre Vascular, Inc. |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
| Feb 10, 2026 | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 componen... | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Class II | Orthalign, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.